Lifileucel for advanced melanoma after progression on immune checkpoint inhibitors and targeted therapies

Patients with advanced melanoma have limited treatment options after progression on immune checkpoint inhibitors (ICIs) and targeted therapies (TTs). Lifileucel is a one-time autologous tumor-infiltrating lymphocyte (TIL) cell therapy. The multicenter phase 2 C-144-01 study evaluated lifileucel for advanced melanoma after progression of ICIs and TTs (median 3 lines of previous therapy). The ORR was 31.4%. At median 27.6 months of follow-up the median duration of response was not reached, while median progression-free survival and overall survival were 4.1 months and 13.9 months, respectively. The most common grade 3-4 treatment-emergent adverse events werd thrombocytopenia (76.9%), anemia (50.0%), and febrile neutropenia (41.7%). The authors conclude that lifileucel had clinically meaningful activity in heavily pretreated patients with advanced melanoma.